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Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165188
Recruitment Status : Active, not recruiting
First Posted : May 24, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Lumos Pharma ( NewLink Genetics Corporation )

Study Description
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Brief Summary:
This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.

Condition or disease
Pancreatic Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 2031
Estimated Study Completion Date : June 2031

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with adverse events. [ Time Frame: Up to 15 years ]
  2. Survival [ Time Frame: Up to 15 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Research subjects who have received at least one dose of algenpantucel-L immunotherapy in clinical trials.
Criteria

Inclusion Criteria:

  • Receipt of at least one dose of algenpantucel-L within the past 15 years
  • Signed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165188


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford University Cancer Center
Palo Alto, California, United States, 94305
United States, Florida
UF Health Cancer Center
Gainesville, Florida, United States, 32610
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
UT Health Cancer Center
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
NewLink Genetics Corporation
More Information
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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT03165188    
Other Study ID Numbers: NLG0705
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No